The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Silver.
Device ID | K040890 |
510k Number | K040890 |
Device Name: | 3M TEGADERM SILVER |
Classification | Dressing, Wound, Drug |
Applicant | 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
Contact | Amy E Short |
Correspondent | Amy E Short 3M COMPANY 3M CENTER, BLDG. 275-5W-06 St. Paul, MN 55144 -1000 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2004-03-24 |
Decision Date | 2004-11-02 |
Summary: | summary |